A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
NCT ID: NCT02354586
Last Updated: 2022-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
463 participants
INTERVENTIONAL
2015-03-23
2021-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Niraparib
Niraparib
Interventions
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Niraparib
Eligibility Criteria
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Inclusion Criteria
* Patients of childbearing potential must have negative pregnancy serum test within 72 hours of being dosed
* Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
* Patients Must have completed 3 or 4 previous chemotherapy regimens.
* Patients must have completed their last chemotherapy regimen \> 4 weeks prior to treatment initiation.
* Patients must have measurable disease according to RECIST (v.1.1).
* Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation.
* Patients must agree to blood samples during screening and at the end of treatment for cytogenetic analysis.
Exclusion Criteria
* Patients must not have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment.
* Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.
* Patients must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active, uncontrolled infection.
* Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
* Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
18 Years
FEMALE
No
Sponsors
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Facing Our Risk of Cancer Empowered
OTHER
Myriad Genetics, Inc.
INDUSTRY
Tesaro, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
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Burbank, California, United States
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Duarte, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Santa Barbara, California, United States
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Stanford, California, United States
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New Haven, Connecticut, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Covington, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Burlington, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Springfield, Missouri, United States
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Hackensack, New Jersey, United States
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Morristown, New Jersey, United States
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East Setauket, New York, United States
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Jamaica, New York, United States
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Lake Success, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Wynnewood, Pennsylvania, United States
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Providence, Rhode Island, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Tyler, Texas, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Sherbrooke, Quebec, Canada
Countries
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References
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Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, Wahner Hendrickson AE, Azodi M, DiSilvestro P, Oza AM, Cristea M, Berek JS, Chan JK, Rimel BJ, Matei DE, Li Y, Sun K, Luptakova K, Matulonis UA, Monk BJ. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):636-648. doi: 10.1016/S1470-2045(19)30029-4. Epub 2019 Apr 1.
Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AO, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, Gonzalez-Martin A. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer. Clin Ther. 2024 Aug;46(8):612-621. doi: 10.1016/j.clinthera.2024.06.001. Epub 2024 Jul 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PR-30-5020-C
Identifier Type: OTHER
Identifier Source: secondary_id
213360
Identifier Type: -
Identifier Source: org_study_id
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